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- Tasks: Lead regulatory activities for a small molecule oncology product globally.
- Company: Join an international pharmaceutical company dedicated to innovative product development.
- Benefits: Contract role with potential extension, offering valuable industry experience.
- Why this job: Make a real impact in oncology while collaborating with top professionals in the field.
- Qualifications: 10+ years in CMC roles, with 5+ years in lifecycle management of small molecules.
- Other info: Proficiency in English required; French is a plus.
The predicted salary is between 48000 - 72000 £ per year.
Regulatory CMC Project Manager – Contract Partnering with an international pharmaceutical company focused on both in house product development and CDMO services, we are now supporting the appointment of a new Regulatory CMC Project Manager to oversee regulatory activities for a small molecule oncology product globally. This position will be a contract until the end of March 2025, with strong likelihood of extension for a further 6 month period. This role involves working independently and with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities. Key responsibilities: Change control procedures Out of specification management CMC commitments and variation submissions Product Quality Review (PQR) production and review Collaboration with external CMOs Manage CMC regulatory activities for clinical programs, including: Authoring INDs and IMPDs Responding to Health Authorities Preparing documents for QP release Post-submission management Key Experience: Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products Experience in pre- and post-approval CMC regulatory activities Effective stakeholder management Project management within a CMC context Knowledge of IND/NDA and IMPD/MAA formats Understanding of drug substance and product CMC Organized, independent, and able to manage multiple activities Degree in Pharmacy or a relevant science/technical subject Language skills: Proficient in English, French is an advantage Regulatory, CMC, project, manager, small, molecule, IND, IMPD, PQR, change, control, quality, assurance, RA, affairs, submission, oncology, cancer, therapy, MAA, marketing, authorisation
Regulatory CMC Project Manager employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory CMC Project Manager
✨Tip Number 1
Make sure to highlight your experience in CMC technical roles, especially your work with small molecule products. This is crucial for demonstrating that you have the relevant background for the Regulatory CMC Project Manager position.
✨Tip Number 2
Familiarize yourself with the specific regulatory requirements for oncology products. Showing that you understand the nuances of this area can set you apart from other candidates.
✨Tip Number 3
Network with professionals in the pharmaceutical industry, particularly those involved in CMC and regulatory affairs. Building connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 4
Prepare to discuss your project management skills in detail. Be ready to share examples of how you've successfully managed multiple CMC activities and collaborated with stakeholders in previous roles.
We think you need these skills to ace Regulatory CMC Project Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory CMC Project Manager position. Highlight key responsibilities and required experiences that align with your background.
Tailor Your CV: Customize your CV to emphasize your relevant experience in CMC technical roles, particularly focusing on small molecule products and lifecycle management. Use specific examples that demonstrate your expertise in change control procedures and regulatory activities.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for oncology and your understanding of the regulatory landscape. Mention your proficiency in English and any additional language skills, like French, that could be beneficial for the role.
Highlight Key Achievements: In both your CV and cover letter, include quantifiable achievements from your previous roles, such as successful IND submissions or effective stakeholder management, to illustrate your capability in managing CMC regulatory activities.
How to prepare for a job interview at RBW Consulting
✨Showcase Your CMC Expertise
Make sure to highlight your extensive experience in CMC technical roles, especially your knowledge of IND/NDA and IMPD/MAA formats. Be prepared to discuss specific projects where you managed lifecycle activities for small molecule products.
✨Demonstrate Stakeholder Management Skills
Prepare examples that illustrate your effective stakeholder management. Discuss how you've collaborated with external CMOs and managed relationships with health authorities during regulatory submissions.
✨Be Ready for Technical Questions
Expect technical questions related to change control procedures, out of specification management, and PQR production. Brush up on these topics and be ready to explain your approach to handling these tasks.
✨Highlight Your Organizational Skills
Since the role requires managing multiple activities independently, emphasize your organizational skills. Share strategies you use to prioritize tasks and ensure timely completion of regulatory activities.
